Pilot, prospective, multicentre, open and non-randomised study: definition of an index of AntiXa value at the end of haemodialysis treatment

Gambro Lundia AB (Sweden)0 个研究点目标入组 60 人开始时间: 2008年7月25日最近更新: 2019年5月5日

适应症

试验速览

•1. Patients suffering from chronic renal failure
•2. Patients treated in haemodialysis (HD) three times a week for at least 3 months, with a stable heparin dose and the same filter
•3. Patients treated in 4 - 4.5 hours HD mode with a blood flow between 300 - 350 ml/min
•4. Patients for whom either low molecular weight heparin (LMWH) (enoxaparin, nadroparin, tinzaparin) or unfractionated heparin (UFH) is used
•5. Patients with a well-functioning vascular access as judged by the investigator
•6. Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device
•7. Patients older than 18 years, either sex
•8. Patients with negative serologies (acquired immune deficiency syndrome [AIDS], hepatitis)
•9. Patients having signed consent to participate in the study

•1. Patient with heparin-induced thrombocytopenia (HIT) or known heparin allergy
•2. Patient treated in HD in single needle mode
•3. Patients with catheter
•4. Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results
•5. Patients participating in other studies that could interfere with the objective of this study
•6. Patients with active malignant disease
•7. Patients receiving heparin outside dialysis treatment
•8. Patients under guardianship
•9. Pregnant women, nursing mothers and women planning a pregnancy during the course of this study
•10. Patients with serious history of coagulopathy
•11. Patients receiving Anti-Vitamin K medication
•12. Patients receiving an association of anti-platelets agents
•13. Patients with heparin dose that can not be reduced for technical reason (excluding patients receiving too low heparin dose with no possibility of further reduction)

发起方

Gambro Lundia AB (Sweden)